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Disposable Trocars
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref AVTB 10-70Model AVTB 5-70Ref AVTC 12-100Ref AVTB 12-70Ref AVTC 15-100Ref AVTC 15-70Ref AVTC 5-70Ref AVTC 12-70Ref AVTC 5-100
Identity
- Trade Name
- Disposable Trocars EUDAMED
- Device Name
- Disposable Trocars EUDAMED
- Model / Reference
- AVTB 5-70 EUDAMEDAVTB 10-70 EUDAMEDAVTC 12-100 EUDAMEDAVTB 12-70 EUDAMEDAVTC 15-100 EUDAMEDAVTC 15-70 EUDAMEDAVTC 5-70 EUDAMEDAVTC 12-70 EUDAMEDAVTC 5-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946480590713 EUDAMED06946480590867 EUDAMED06946480590744 EUDAMED06946480590898 EUDAMED06946480590881 EUDAMED06946480590706 EUDAMED06946480590799 EUDAMED06946480590850 EUDAMED06946480590805 EUDAMED
- Basic UDI-DI
- 69464805AVT6C EUDAMED
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Trocars by Sinolinks Medical Innovation, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250820 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69464805AVT6C | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sinolinks Medical Innovation, Inc.
- EUDAMED SRN
- CN-MF-000010840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (10)
- EUDAMED 38bc4222-9863-45f6-9c27-238dc1b490ba 61 fields · synced Oct 6, 2026
- EUDAMED fad4f7d1-179c-4957-89d5-ca4fc902a120 61 fields · synced May 11, 2026
- EUDAMED 3c9ada23-ce81-40c1-9efc-cf39d1b5c886 61 fields · synced May 16, 2026
- EUDAMED b7fc77da-f345-40d8-94ba-6d0e8e6c83aa 61 fields · synced May 16, 2026
- EUDAMED 43bb2553-408d-41a5-99b3-bc961a853e02 61 fields · synced May 17, 2026
- EUDAMED 593759f2-5f34-4d33-ae2c-70355734672c 61 fields · synced May 17, 2026
- EUDAMED 0f5f5b99-f0c7-4cda-be2c-cb62f7d42f8e 61 fields · synced May 18, 2026
- EUDAMED f1462d5c-0b2d-4e50-aa27-021ffcc83ae0 61 fields · synced May 18, 2026
- EUDAMED 418a80d4-867d-464a-a666-1408e2828a4f 61 fields · synced May 19, 2026
- FDA 510(k) K250820 1 fields · synced May 18, 2026